Program Manager - R&D

Position Summary:

The Program Manager has overall accountability for programs and projects from concept through launch. The Program Manager is responsible to ensure the Core Team is on track following the established and approved business plan. The Program Manager is responsible for presenting issues, recommendations and updates in regard to their programs. The PM has the required skills to form high performing teams that will result in the timely and high-quality execution of the assigned program(s).

Essential Duties & Responsibilities:

• Generates analyses of timeline (schedule), resource, and budget information that facilitates scenario & contingency planning, risk assessment and decision-making.
• Maintains program schedule, monitors and tracks team performance metrics (time, cost and quality milestones) relative to the approved project plan.
• Collects, analyzes, integrates, and maintains cross-functional deliverables (i.e. Integrated Project Plans).
• Drives day-to-day Project Team activities to meet project milestones and keep functions on track in compliance with Corporate and Site policies and procedures. Understands critical path activities and anticipates steps that may be bottlenecks.
• Develops and executes communication plan to ensure effective and timely communication between the Core Team and functional management, senior management, and external partners.
• Organizes and facilitates effective meetings. Identifies and delegates action items, follow-up/track action items to resolution, updates project plans & deliverables, as required, identifies issues and ultimately resolves issues off-line (to ensure effective meetings at all levels), with subsequent escalation as required.
• Prepares periodic program status reports as requested by management.
• As required to meet timelines, executes program elements (e.g. coordinate validation activities) as a team member.
• Validation execution and coordination: will be trained in equipment and process validation as required.
• Perform other related duties as assigned or required.

Knowledge, Skills & Qualifications:

• Well demonstrated expertise in leading and managing cross-functional teams to achieve objectives in a highly matrixed environment.
• Must have strong written and verbal communication skills (including presentation skills), advanced technical writing capability, and expertise in development of risk mitigation strategies.
• Basic knowledge of functions as related to their particular program assignments is essential. The incumbent should also have demonstrated successful leadership competencies (diligence, planning, analysis, and communication).
• Both fundamental and advanced program management skills are necessary to complete the work including advanced knowledge and hands-on experience with MS Office, including Visio and Project).

Education and Experience:

• Bachelor’s Degree is required: Engineering, Physical Sciences, Chemistry, Pharmacy or related fields.
• PMP, preferred, not required
• 5+ years’ experience, including 5 years’ experience in the Pharma Industry in a program/project management-related capacity, including product development and/or licensed pharma product change management process experience.
• Cross-functional experience in different areas such as Development, Quality, Medical, Commercial, Manufacturing Operations, Clinical or Regulatory is preferred but not required. Experience in managing program budgets is required and vendor management / interaction is a plus.

Minimum Qualifications:

• Must be at least 18 years of age

Travel Requirements:

• Typically requires travel 5-20% of the time

Physical Requirements and Work Environment:

• The majority of the duties are performed in an office work environment.
• May be required to travel globally (limited).
• Cleanroom and/or manufacturing environment to support project team executions, validation efforts, start-ups, or first lot executions.
• Ability to work night, weekend and holiday hours as required by projects and by support needs for a 24/7 operation.
• Must have adequate manual dexterity and coordination to operate standard office equipment. Must be able to gown into a controlled manufacturing area and remain for up several hours during project execution.
• If traveling internationally, must be able to sit for extended periods of time.